Lead Data Manager

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

RESPONSIBILITIES

• Electronic data capture (EDC) experience:
• At least two (2) years of experience with a major EDC tool (InForm, RAVE, Oracle Clinical, or similar)
• Study startup/build activities, including working with a standards library
• User Acceptance Testing (UAT)
• Data Review and Cleaning (running of queries and reports)
• Data Reconciliation
• Database Lock
• Extensive experience managing study start-up, conduct, and lock in the data management space:
• Knowledge of, and familiarity with a Standards Library, and the mapping of protocols to data standards
• Success in conducting/leading meetings, including User Review (OLSR – Online Screen Review) meetings
• Involvement with cross-functional teams, including Programming and Biostatistics
• Experience with external data vendors: understanding specifications to import multiple types of data, working with technical groups to ensure timely loads of external data sets into the sponsor's database.
• Knowledge of ePRO/eCOA instruments, and their use in clinical studies.
• Documented experience in translating clinical protocols into electronic case report forms and developing the associated data validation specifications (e.g., edit checks, reports).
• Proven ability to run multiple concurrent studies while also participating in special projects or process improvement initiatives.
• Ability to represent the department on cross-functional study teams and cross-functional project teams.
• Demonstrated experience in providing customer-focused support, with satisfactory examples provided.
• Excellent written and verbal communication skills.
• Strong presentation skills, including the ability to represent yourself and the department in front of customers and stakeholders.
• Ability to work within short and compressed study timelines.
• Ability to multi-task, work independently, and act with appropriate accountability.
• Understanding logistics in the laboratory space (e.g., PK/PD analysis, sample management, etc.)

QUALIFICATIONS

Required:

• 4+ years of clinical data management experience.
• Lead Data Manager experience within Phase I.

Preferred but not required:

• 1+ year(s) of experience as a Lead Data Manager within Phase I, including having completed at least one (1) study start/setup and one (1) database lock.
• BA/BS degree or higher, but not required if supplemented by sufficient work experience.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.